Trial reportThe American journal of gastroenterology2011
High-dose ursodeoxycholic acid is associated with the development of colorectal neoplasia in patients with ulcerative colitis and primary sclerosing cholangitis.
Trial report in The American journal of gastroenterology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 106 papers, 7 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
106 citing papers in PubMed, 7 syntheses or guidelines pooled it, 264 citations in OpenAlex.
- [Guidelines on the diagnosis and management of primary sclerosing cholangitis (2021)].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2022Guideline
- Cholecystectomy promotes the development of colorectal cancer by the alternation of bile acid metabolism and the gut microbiota.Frontiers in medicine · 2022Pooled it
- Assessment of extraintestinal manifestations in inflammatory bowel diseases: A systematic review and a proposed guide for clinical trials.United European gastroenterology journal · 2020Pooled it
- Guideline
- Clinical guidelines for primary sclerosing cholangitis 2017.Journal of gastroenterology · 2018Guideline
- ACG Clinical Guideline: Primary Sclerosing Cholangitis.The American journal of gastroenterology · 2015Guideline
- Ursodiol and colorectal cancer or dysplasia risk in primary sclerosing cholangitis and inflammatory bowel disease: a meta-analysis.Digestive diseases and sciences · 2013Pooled it
- Ursodeoxycholic acid counteracts celecoxib in reduction of duodenal polyps in patients with familial adenomatous polyposis: a multicentre, randomized controlled trial.Orphanet journal of rare diseases · 2013Trial
- Article
- Evaluation and management of primary sclerosing cholangitis patients awaiting liver transplantation.JHEP reports : innovation in hepatology · 2026Review
- Graft and Patient Survival After Liver Transplantation for Primary Sclerosing Cholangitis: A French National Cohort Study.Liver international : official journal of the International Association for the Study of the Liver · 2026Article
- Japanese Society for Cancer of the Colon and Rectum (JSCCR) Guidelines 2024 for the Clinical Practice of Inflammatory Bowel Disease-Associated Intestinal Neoplasia (English Version).Journal of the anus, rectum and colon · 2026Review
- The history and future of bile acid therapies.Journal of hepatology · 2025Article
- Navigating Neoplasm Risk in Inflammatory Bowel Disease and Primary Sclerosing Cholangitis.Cancers · 2025Review
- Clinical management of autoimmune liver diseases: juncture, opportunities, and challenges ahead.Immunologic research · 2025Review
- Open Label Vancomycin in Primary Sclerosing Cholangitis-Inflammatory Bowel Disease: Improved Colonic Disease Activity and Associations With Changes in Host-Microbiome-Metabolomic Signatures.Journal of Crohn's & colitis · 2025Observational
- Review
- Current status of pharmacotherapy for primary sclerosing cholangitis.Frontiers in medicine · 2025Review
- Management of primary sclerosing cholangitis: Current state-of-the-art.Hepatology communications · 2024Review
- Disentangling the molecular mystery of tumour-microbiota interactions: Microbial metabolites.Clinical and translational medicine · 2024Review
46 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
13 authors at 7 institutions in 2 countries.
Funding
Abstract
objectivesSome studies have suggested that ursodeoxycholic acid (UDCA) may have a chemopreventive effect on the development of colorectal neoplasia in patients with ulcerative colitis (UC) and primary sclerosing cholangitis (PSC). We examined the effects of high-dose (28-30 mg/kg/day) UDCA on the development of colorectal neoplasia in patients with UC and PSC.
methodsPatients with UC and PSC enrolled in a prior, multicenter randomized placebo-controlled trial of high-dose UDCA were evaluated for the development of colorectal neoplasia. Patients with UC and PSC who received UDCA were compared with those who received placebo. We reviewed the pathology and colonoscopy reports for the development of low-grade or high-grade dysplasia or colorectal cancer.
resultsFifty-six subjects were followed for a total of 235 patient years. Baseline characteristics (including duration of PSC and UC, medications, patient age, family history of colorectal cancer, and smoking status) were similar for both the groups. Patients who received high-dose UDCA had a significantly higher risk of developing colorectal neoplasia (dysplasia and cancer) during the study compared with those who received placebo (hazard ratio: 4.44, 95% confidence interval: 1.30-20.10, P=0.02).
conclusionsLong-term use of high-dose UDCA is associated with an increased risk of colorectal neoplasia in patients with UC and PSC.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.